États-Unis - anglais - NLM (National Library of Medicine)

zydus lifesciences limited - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: -   major depressive disorder [see clinical studies (14.1)] -   generalized anxiety disorder [see clinical studies (14.2)] -   diabetic peripheral neuropathy [see clinical studies (14.3)] -   chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and  warnings and precautions (5.4)] . pregn

États-Unis - anglais - NLM (National Library of Medicine)

rising pharmaceuticals, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 10 mg - alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)] . alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)] . alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4)] . alendronate sodium tablets are indicated for the treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget's disease of bone who have al

États-Unis - anglais - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - amlodipine 5 mg - amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (cv) events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. individual blood pressure goals may vary based upon the patient’s risk. data from an 8-week, placebo-controlled, parallel-group factorial study [see clinical studies (14.1) ] provide estimates of the probability of reaching a blood pressure goal with amlodipine and olmesartan medoxomil tablets compared to amlodipine or olmesartan medoxomil monotherapy. the figures below provide estimates of the likelihood of achieving the targeted systolic or diastolic blood pressure goals with amlodipine and olmesartan medoxomil tablets 10/40 mg compared with amlodipine or olmesartan medoxomil monotherapy, based upon baseline systolic or diastolic blood pressure. the curve of each treatment group was estimated by logistic regression modeling from all available data of that treatment group. the right tail of each curve is less reliable because of small numbers of subjects with high baseline blood pressures. figure 1: probability of achieving systolic blood pressure (sbp) < 140 mmhg at week 8 with locf figure 2: probability of achieving diastolic blood pressure (dbp) < 90 mmhg at week 8 with locf figure 3: probability of achieving systolic blood pressure (sbp) < 130 mmhg at week 8 with locf figure 4: probability of achieving diastolic blood pressure (dbp) < 80 mmhg at week 8 with locf the figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal (e.g., week 8 sbp <140 mmhg or <130 mmhg or a dbp <90 mmhg or <80 mmhg) for the high-dose treatment groups evaluated in the study. amlodipine and olmesartan medoxomil tablets 5/20 mg, the lowest dose combination treatment group, increases the probability of reaching blood pressure goal compared with the highest dose monotherapies, amlodipine 10 mg and olmesartan medoxomil 40 mg. for example, a patient with a baseline blood pressure of 160/100 mmhg has about a 48% likelihood of achieving a goal of <140 mmhg (systolic) and a 51% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with olmesartan medoxomil 40 mg, and about a 46% likelihood of achieving a goal of <140 mmhg (systolic) and a 60% likelihood of achieving a goal of <90 mmhg (diastolic) on monotherapy with amlodipine 10 mg. the likelihood of achieving these same goals increases to 63% (systolic) and 71% (diastolic) on amlodipine and olmesartan medoxomil tablets 5/20 mg, and to 68% (systolic) and 85% (diastolic) on amlodipine and olmesartan medoxomil tablets 10/40 mg. do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [see drug interactions (7.2)] . risk summary amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see clinical considerations] . most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. when pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible. consider alternative antihypertensive therapy during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions olmesartan medoxomil oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to olmesartan, if oliguria or hypotension occur, utilize measures to maintain adequate blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function [see use in specific populations (8.4)]. data animal data no reproductive studies have been conducted with the combination of olmesartan medoxomil, and amlodipine. however, these studies have been conducted for olmesartan medoxomil and amlodipine alone. olmesartan medoxomil no teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose [mrhd] on a mg/m2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the mrhd on a mg/m2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the dose). in rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricular, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. the no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the mrhd of 40 mg/day. amlodipine no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses of up to 10 mg amlodipine/kg/day (respectively about 10 and 20 times the maximum recommended human dose of 10 mg amlodipine on a mg/m2 basis) during their respective periods of major organogenesis (calculations based on a patient weight of 60 kg). however, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestational period and the duration of labor in rats at this dose. risk summary there is limited information regarding the presence of amlodipine and olmesartan medoxomil tablets in human milk, the effects on the breastfed infant, or the effects on milk production. amlodipine is present in human milk. olmesartan is present in rat milk [see data]. because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment with amlodipine and olmesartan medoxomil tablets. data presence of olmesartan in milk was observed after a single oral administration of 5 mg/kg [14c] olmesartan medoxomil to lactating rats. the safety and effectiveness of amlodipine and olmesartan medoxomil tablets in pediatric patients have not been established. of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 20% (384/1940) were 65 years of age or older and 3% (62/1940) were 75 years or older. no overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects. elderly patients have decreased clearance of amlodipine. starting amlodipine or adding amlodipine at 2.5 mg in patients ≥75 years old is recommended. the lowest dose of amlodipine and olmesartan medoxomil tablets is 5/20 mg; therefore, initial therapy with amlodipine and olmesartan medoxomil tablets is not recommended in patients ≥75 years old. amlodipine. reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40% to 60%, and a lower initial dose may be required. olmesartan medoxomil. of the total number of hypertensive patients receiving olmesartan medoxomil in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. no overall differences in effectiveness or safety were observed between elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with hepatic insufficiency, but both amlodipine and olmesartan medoxomil show moderate increases in exposure in patients with hepatic impairment. the recommended initial dose of amlodipine in patients with severe hepatic impairment is 2.5 mg, a dose not available with amlodipine and olmesartan medoxomil tablets. amlodipine. amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t½) is 56 hours in patients with severely impaired hepatic function [see warnings and precautions (5.5)] . olmesartan medoxomil . increases in auc0-∞ and peak plasma concentration (cmax ) for olmesartan were observed with moderate hepatic impairment compared to those in matched controls with an increase in auc of about 60%. there are no studies of amlodipine and olmesartan medoxomil tablets in patients with renal impairment. amlodipine. the pharmacokinetics of amlodipine are not significantly influenced by renal impairment. patients with renal failure may therefore receive the usual initial dose. olmesartan medoxomil. patients with renal insufficiency have elevated serum concentrations of olmesartan compared with patients with normal renal function. after repeated dosing, auc was approximately tripled in patients with severe renal impairment (creatinine clearance <20 ml/min). no initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min). of the total number of subjects in the double-blind clinical study of amlodipine and olmesartan medoxomil tablets, 25% (481/1940) were black patients. amlodipine and olmesartan medoxomil tablets was effective in treating black patients (usually a low-renin population), and the magnitude of blood pressure reduction in black patients approached that observed for non-black patients.

États-Unis - anglais - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - desvenlafaxine succinate (unii: zb22enf0xr) (desvenlafaxine - unii:ng99554anw) - desvenlafaxine 50 mg - pristiq is indicated for the treatment of adults with major depressive disorder (mdd) [see clinical studies (14)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185. risk summary based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.4) and clinical considerations] . there are no published studies on pristiq in pregnant women; however published epidemiologic studies of pregnant women exposed to venlafaxine, the parent compound, have not reported a clear association with adverse developmental outcomes (see data) . there are risks associated with untreated depression in pregnancy and with expos

États-Unis - anglais - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of ven

États-Unis - anglais - NLM (National Library of Medicine)

proficient rx lp - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. meloxicam tablet are indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1)]. meloxicam tablets are contraindicated in patients with known hypersensitivity (e.g. anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.13)]. meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. there are no adequate and well-controlled studies in pregnant women. meloxicam crosses the placental barrier. prior to 30 weeks gestation, use meloxicam during

États-Unis - anglais - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated [see indications and usage ( 1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults) - mycoplasma pneumoniae, streptococcus pneumoniae, chlamydophila pneumoniae (in adults and pediatric patients) clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or s treptococcus pyogenes . clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies ( 14.2)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or myc obacterium intracellulare in patients with advanced hiv infection [see clinical studies ( 14.1 )] . clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies ( 14.3 )] . - clarithromycin tablets in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions ( 5.1)] . concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see drug interactions ( 7)] . there have been postmarketing reports of drug interactions when clarithromycin is co‑administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. fatalities have been reported. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment. concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin tablets with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions ( 7)] . concomitant administration of clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see drug interactions ( 7) ]. for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section). risk summary based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions ( 5.7)]. limited data from a small number of published human studies with clarithromycin tablets use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison. fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin. in pregnant mice, clarithromycin was administered during organogenesis (gestation day [gd] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [mrhd] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. at ≥ 500 mg/kg/day, increases in the incidence of post-implantation loss and cleft palate in the fetuses were observed. no adverse developmental effects were observed in mice at ≤ 250 mg/kg/day (≤ 1 times mrhd based on body surface area comparison). in pregnant sprague dawley rats, clarithromycin was administered during organogenesis (gd 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. reductions in body weight and food consumption was observed in dams at 150 mg/kg/day. increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. additionally, at 150 mg/kg/day (1 times mrhd based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, iv septal defect) was observed in the fetuses. clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times mrhd based on body surface area comparison). intravenous dosing of clarithromycin during organogenesis in rats (gd 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant wistar rat, clarithromycin was administered during organogenesis (gd 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant rabbits, clarithromycin administered during organogenesis (gd 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times mrhd based on body surface area comparison). intravenously administered clarithromycin to pregnant rabbits during organogenesis (gd 6 to 18) in rabbits at 20, 40, 80, or 160 mg/kg/day (≥ 0.3 times mrhd based on body surface area comparison) resulted in maternal toxicity and implantation losses at all doses. in pregnant monkeys, clarithromycin was administered (gd 20 to 50) at oral doses of 35 or 70 mg/kg/day. dose-dependent emesis, poor appetite, fecal changes, and reduced body weight were observed in dams at all doses (≥ 0.5 times mrhd based on body surface area comparison). growth retardation in 1 fetus at 70 mg/kg/day was considered secondary to maternal toxicity. there was no evidence of primary drug related adverse developmental effects at any dose tested. in a reproductive toxicology study in rats administered oral clarithromycin late in gestation through lactation (gd 17 to post-natal day 21) at doses of 10, 40, or 160 mg/kg/day (≤ 1 times mrhd based on body surface area comparison), reductions in maternal body weight and food consumption were observed at 160 mg/kg/day. reduced body-weight gain observed in offspring at 160 mg/kg/day was considered secondary to maternal toxicity. no adverse developmental effects were observed with clarithromycin at any dose tested. risk summary based on limited human data, clarithromycin and its active metabolite 14-oh clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose (see data). in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin (see data). no data are available to assess the effects of clarithromycin or 14-oh clarithromycin on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for clarithromycin tablets and any potential adverse effects on the breast-fed child from clarithromycin tablets or from the underlying maternal condition. data human serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin tablets 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. males administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see nonclinical toxicology ( 13.1)]. the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well- controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies ( 14.2 )] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin tablets for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin tablets every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions ( 5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions ( 5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see contraindications ( 4.4) and warnings and precautions ( 5.4)] . clarithromycin tablets are principally excreted via the liver and kidney. clarithromycin tablets may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration ( 2.5 )] .

États-Unis - anglais - NLM (National Library of Medicine)

contract pharmacy services-pa - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. the efficacy of divalproex sodium was established in 3 week trials with patients meeting dsm-iii-r criteria for bipolar disorder who were hospitalized for acute mania [see clinical studies ( 14.1)] . the safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. divalproex sodium

États-Unis - anglais - NLM (National Library of Medicine)

rebel distributors corp. - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine 15 mg - amrix is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. amrix should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. amrix has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. - hypersensitivity to any component of this product. - concomitant use of monoamine oxidase (mao) inhibitors or within 14 days after their discontinuation. - hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or

États-Unis - anglais - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients  - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see warnings and precautions ( 5.1)] .  - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (